Guidelines for Medical Device Applicability of Programs

Guidelines for Medical Device Applicability of Programs

The Ministry of Health, Labor and Welfare (MHLW) has announced that as of March 31, 2021, “Guidelines on Medical Device Eligibility for ProgramsThe “Guidelines on the Medical Device Applicability of Programs” (NHI Directive No. 0331-1 / NHI Marijuana Directive No. 0331-15) was issued by the Ministry of Health, Labour and Welfare (MHLW).
This guideline provides criteria for determining which programs do/do not qualify as medical devices.

Programs that fall under the category of medical devices with respect to medical device applicability

The guidelines list the following as programs that fall under the category of medical devices
　1. Programs that display disease candidates and disease risks based on input information
　2. Programs intended to diagnose, treat, and prevent disease

• Programs that process and process data (including images) obtained from medical devices to create indicators, images, graphs, etc. for use in diagnosis or treatment
• Programs (including simulations) to assist in determining treatment plans and methods
• Programs to control medical devices, or programs that connect to medical devices to extend the functionality of medical devices for the purpose of analyzing medical device data

　3. Programs used in sets with tangible medical devices

Programs that do not qualify as medical devices

In addition, the following programs that do not fall under the category of medical devices are listed.
　1．Programs intended for personal use

• Programs that do not process or handle data (only display, store, or transfer)
• Programs for non-medical and non-health purposes such as exercise management
• Programs designed to provide information to users

　2．Programs intended for use by health care professionals

• Programs for the sole purpose of providing information not used to make medical decisions to health care professionals, patients, etc.
• Programs for in-hospital operational support and maintenance
• Programs that only store and transfer data
• Programs that process and process data for purposes other than diagnosis and treatment
• Programs that only process according to diagnostic and treatment guidelines, etc.

　3．Programs that perform processing equivalent to general medical devices (Class I medical devices) (those that pose little risk of affecting human life and health in the event of functional impairment, etc.)

Consultation Service for Programmed Medical Devices

Although the guidelines have been issued, there may be some confusion as to whether or not a specific individual product qualifies as a medical device.
The Ministry of Health, Labour and Welfare (MHLW) has opened a consultation service for businesses seeking to develop programmed medical devices (consultation on the applicability of the program to medical devices, consultation on pharmaceutical development of programmed medical devices, and consultation on medical insurance) from April 1, 2021.
As for the consultation service, see notice here.

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